Release for the EU
According to European Directives, all batches of drugs are subject to quality control by a national authority.
The SYNERLAB Group is authorised as an importer by the ANSM and in this capacity, it may inspect drugs obtained from non-EU countries and release them for the EU market.
Authorised import operations
The BTT Laboratories have been authorised in this context by the AFSSAPS as a manufacturing and importing site, according to decision M09/393.
The following import operations are authorised:
- Quality control for imported drugs (microbiology excluding sterility and physical chemistry tests)
- Releasing of imported drugs (non-sterile products). The imported pharmaceutical specialities may originate from different countries.
- Third countries that have not signed an Agreement on Mutual Recognition with the European Union; in this case, the products must be re-analysed in the European Union before being released in the EU.
- Third countries that have signed an Agreement on Mutual Recognition (AMR) with the European Union (Switzerland, Australia, New Zealand, Canada); in this case, the speciality is released in the European Union without the analytical verifications having to be repeated.
General and statutory documentation
The principal is required to provide the BTT Laboratories with the following documentation :
- technical marketing authorisation file (manufacturing and control),
- authorisation for the opening of a production site (and any amendments to the latter),
- GMP certificate of the production site,
- copy of marketing authorisation naming the BTT Laboratories as the inspection and release site for the imported pharmaceutical speciality,
- any amendments to the marketing authorisation (change of process, change of supplier of the main active ingredient, change of specifications, etc.) and printed final proof of a packaging item,
- any new version of the manufacturing or packaging instructions,
- To obtain authorisation to release a speciality manufactured in a country within the European Union or the European Economic Area, the principal must provide the BTT laboratories with a complete batch file in French or English including the following elements at least:
- the manufacturing formula,
- the complete manufacturing supervision details (weight, mixture, composition, packaging),
- the analysis reports on all the substances involved in the manufacturing of the batch,
- the analysis reports on the finished product,
- the certification of the batch by the manufacturer’s qualified representative (according to the harmonised model for products obtained from third countries who have signed an AMR),
- detailed descriptions and notifications of discrepancies or incidents occurring during production with an explanation of any corrective action (e.g. analytical non-conformities, results outside the specifications during in-process controls, etc.).